Naloxegol in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer

Description

This randomized pilot clinical trial studies the side effects and best dose of naloxegol and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer. Naloxegol may relieve some of the side effects of opioid pain medication and fight off future growth in the cancer.

Study Start Date

October, 13 2017

Estimated Completion Date

October 2020

Interventions

  • Drug: Naloxegol
  • Other: Placebo
  • Other: Laboratory Biomarker Analysis
  • Other: Quality-of-Life Assessment

Study ID

Alliance for Clinical Trials in Oncology -- A221504

Status

Recruiting

Trial ID

NCT03087708

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

204

Sponsor

Alliance for Clinical Trials in Oncology

Inclusion Criteria

  • Advanced (stage IIIB or IV) lung adenocarcinoma diagnosed by biopsy of the primary or metastatic site (American Joint Committee on Cancer 7.0)
  • No known presence of known EGFR or EML4-ALK driver mutations in the tumor
  • Initiation of first-line chemotherapy with a platinum-pemetrexed-based regimen within 14 days of registration or planning to initiate within 14 days after registration
  • no planned initiation of definitive (potentially curative) concurrent chemo-radiation
  • No prior systemic therapy for advanced NSCLC, including chemotherapy, targeted therapy or immunotherapy
  • prior palliative radiation permitted prior adjuvant chemotherapy/radiation is permitted
  • No past or current use of mixed opioid agonist/opioid antagonists or other opioid antagonists
  • No methadone within 4 weeks prior to registration
  • Patients must have used opioid medication(s) for pain at some time in the 4 weeks prior to registration
  • current use of opioids (at the time of registration) and/or later during the course of the study is permitted but not required
  • Expected survival > 3 months
  • No concurrently active second invasive malignancies except non-melanoma skin cancer
  • No history of gastrointestinal obstruction, or conditions that increase the risk of gastrointestinal obstruction, perforation, bleeding or impairment of the gastrointestinal wall
  • no abdominal surgery within 60 days of registration
  • No acute gastrointestinal conditions, such as: obstruction, fecal impaction, obstipation, acute surgical abdomen, ongoing need for manual maneuvers to induce bowel movements (such as digital evacuation)
  • No conditions that may compromise blood-brain barrier permeability (e.g., multiple sclerosis, recent brain trauma, Alzheimer's disease, or uncontrolled seizures)
  • No symptomatic and untreated brain metastases
  • patients will be eligible for study if radiation therapy for brain metastases was completed at least 7 days prior to registration
  • Patients having received stereotactic radiation will be eligible if the radiation was completed at least 7 days prior to registration
  • Patients having undergone surgical resection of brain metastases will be eligible after they have healed and recovered from the surgical intervention sufficiently to start systemic treatment for NSCLC, as determined by a neurosurgeon
  • No known leptomeningeal carcinomatosis
  • No history of myocardial infarction =< 6 months prior to registration
  • no current symptomatic congestive heart failure, uncontrolled angina, or uncontrolled cardiac arrhythmias
  • No severe hepatic impairment (Child-Pugh class C) or acute liver disease
  • No known serious or severe hypersensitivity reaction to naloxegol or any of its excipients
  • No concurrent use of moderate/strong CYP3A4 inhibitors, or strong CYP3A4 inducers
  • Not pregnant and not nursing
  • for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required a female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
  • Age ? 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Calculated (calc.) creatinine clearance >= 60 mL/min calculated using the Cockcroft-Gault formula
  • Total bilirubin =< 1.2 x upper limit of normal (ULN) unless due to Gilbert's disease
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (4)

Study Location Distance Name Phone Email
Alliance for Clinical Trials in Oncology - Boston, Massachusetts 2.6 miles Pankaj Gupta MD 612-467-4135 pankaj.gupta@va.gov
Alliance for Clinical Trials in Oncology - Boston, Massachusetts 2.6 miles Pankaj Gupta MD 612-467-4135 pankaj.gupta@va.gov
Alliance for Clinical Trials in Oncology - Boston, Massachusetts 2.6 miles Pankaj Gupta MD 612-467-4135 pankaj.gupta@va.gov
Alliance for Clinical Trials in Oncology - Boston, Massachusetts 2.6 miles Pankaj Gupta MD 612-467-4135 pankaj.gupta@va.gov

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